FDA Recognizes SeaStar Medical’s Groundbreaking Device
SeaStar Medical Holding Corporation (Nasdaq: ICU) has secured the U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for its innovative Selective Cytopheretic Device (SCD). This cell-directed solution aims to mitigate hyper-inflammation’s damaging effects on critical organs, specifically for ICU patients suffering from acute kidney injury (AKI) and acute on chronic liver failure.
The SCD’s Distinctive Advantage
Dr. Kevin Chung, Chief Medical Officer of SeaStar Medical, underscores the device’s potential. He notes the alarming mortality linked to hepatorenal syndrome – a condition marked by rapid kidney function decline in patients with advanced liver cirrhosis. Observations suggest that the SCD could be a game-changer, enhancing the likelihood of patients’ eligibility for potentially life-saving liver transplants.
The Staggering Impact of Hepatorenal Syndrome
The Current Scenario
Hepatorenal syndrome’s grim prognosis is undeniable, with most patients succumbing to renal failure mere weeks after its onset. Shockingly, patients with severe acute on chronic liver failure with four or more organ failures face a 100% mortality rate within 28 days. An estimated 700,000 hepatorenal syndrome cases emerge in the U.S. yearly, with the 2019 hospitalization costs for the syndrome estimated at a staggering $4.2 billion.
A Ray of Hope with the SCD
A pilot study at the University of Michigan brought forth encouraging outcomes. Two patients with type 1 hepatorenal syndrome were treated using the SCD, resulting in positive clinical outcomes. Notably, one individual, post-SCD treatment, was undergoing evaluation for a liver transplant, while the other successfully received a liver transplant shortly after the SCD therapy concluded. This evidence underscores the potential of the SCD as a pivotal treatment for hepatorenal syndrome.
SeaStar’s Continuous Achievements and Vision
Recognitions and Endorsements
Eric Schlorff, CEO of SeaStar Medical, expresses gratitude for the FDA’s continued recognition. Following Breakthrough Device Designations for adult AKI in 2022 and cardiorenal syndrome, this marks the third accolade for the SCD. The award from the FDA’s Center for Biologics Evaluation and Research (CBER) solidifies the potential of the SCD’s approach in targeting imbalanced immune responses. Schlorff further elaborates on the SCD’s potential in treating various conditions like sepsis, AKI, cardiorenal syndrome, and COVID-19.
The Science Behind Hyperinflammation and the SCD
Hyperinflammation can lead to catastrophic damage to vital organs. This overactivity stems from an excessive production of inflammatory cells, leading to the feared cytokine storm. Unique from other treatments, the SCD focuses on the most activated proinflammatory neutrophils and monocytes. Through creating a specific micro-environment, the SCD neutralizes these cells, signaling the body to prioritize repair.
About SeaStar Medical
Redefining extracorporeal therapies, SeaStar Medical is at the forefront of producing life-saving solutions for critically ill patients. By targeting effector cells causing systemic inflammation, the company is shaping a new era of medical treatments. With its innovative approach and FDA’s continued recognition, SeaStar Medical is well-positioned to bring a paradigm shift in treating hyperinflammation-related complications, potentially saving numerous lives in the process.
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